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PHARMACY UPDATE

PHARMACY UPDATE

Understanding Exculpatory Clauses

By Julie A. Tyk, JD

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An exculpatory clause purports to deny an injured party the right to recover damages from a person negligently causing his injury. Cain v. Banka, 932 So. 2d 575 (Fla. 5th DCA 2006). They are disfavored in the law because they relieve one party of the obligation to use due care and shift the risk of injury to the party who is probably least equipped to take the necessary precautions to avoid injury and bear the risk of loss. Applegate v. Cable Water Ski, L.C., 974 So. 2d 1112, 1114 (Fla. 5th DCA 2008). Such clauses are strictly construed against the party seeking to be relieved of liability. Sunny Isles Marina, Inc. v. Adulami, 706 So. 2d 920 (Fla. 3d DCA 1998). Thus, exculpatory clauses are enforceable, only where, and to the extent, that the intention to be relieved from liability is made clear and unequivocal. Tatman v. Space Coast Kennel Club, Inc., 27 So. 3d 108, 110 (Fla. 5th DCA 2009). The wording must be so clear and understandable that “an ordinary and knowledgeable person will know what he is contracting away.” Id. (quoting Gayon v. Bally’s Total Fitness Corp., 802 So. 2d 420 (Fla. 3d DCA 2001).

The seminal Florida case on exculpatory clauses is the Florida Supreme Court case of Sanislo v. Give Kids The World, Inc., 157 So. 3d 256 (Fla. 2015). Give Kids the World, Inc. (“GKTW”) provided free vacations to seriously ill children and their families. When applying for the vacation, the Sanislos executed a “wish request” form that contained a waiver of liability, also known as an exculpatory clause. When the parents arrived at the resort village they again signed a liability release form, also an exculpatory clause. The language of the exculpatory clause is reprinted below for reference:

I/we hereby release Give Kids the World, Inc. and all of its agents, officers, directors, servants, and employees from any liability whatsoever in connection with the preparation, execution, and fulfillment of said wish, on behalf of ourselves, the above named wish child and all other participants. The scope of this release shall include, but not be limited to, damages or losses or injuries encountered in connection with transportation, food, lodging, medical concerns (physical and emotional), entertainment, photographs and physical injury of any kind....

I/we further agree to hold harmless and to release Give Kids the World, Inc. from and against any and all claims and causes of action of every kind arising from any and all physical or emotional injuries and/or damages which may happen to me/us....

Sanislo at 258-259.

While participating in a horse-drawn wagon ride, a rear pneumatic lift designed to allow those in wheelchairs to participate failed, and Ms. Sanislo was injured. The Sanislos brought suit and GKTW filed a motion for summary judgment arguing that the signed releases precluded an action for negligence. The Sanislos filed a motion for partial summary judgment against GKTW’s affirmative defense of release. The trial court granted the Sanislo’s motion and denied GKTW’s motion. The jury found for the Sanislos and GKTW appealed. Id.

The Fifth District reversed, finding the lower court erred in denying GKTW’s motion for summary judgment because the release signed by the Sanislos was unambiguous and did not contravene public policy. It ruled the exculpatory clause barred the negligence action despite the lack of a specific reference to “negligence” or “negligent acts” in the exculpatory clause.

The Fifth District reasoned that exculpatory clauses are effective if the wording of the exculpatory clause is clear and understandable so that an ordinary and knowledgeable person would know what he or she is contracting away, and that the court had previously rejected “‘the need for express language referring to release of the defendant for “negligence” or “negligent acts” in order to render a release effective to bar a negligence action.’ ” On the public policy argument, the Court said the relative bargaining power of the parties should not be considered because it was outside of the public utility or public function context and the Sanislos were not required to request a vacation with GKTW or go on the vacation. Id.

In affirming the Fifth District’s decision, the Supreme Court wrote that the conflict for the Court’s resolution was “whether an exculpatory clause is ambiguous and thus ineffective to bar a negligence action due to the absence of express language releasing a party from its own negligence or negligent acts.” Id. at 260.

The Florida Supreme Court wrote: .... we are reluctant to hold that all exculpatory clauses that are devoid of the terms “negligence” or “negligent acts” are ineffective to bar a negligence action despite otherwise clear and unambiguous language indicating an intent to be relieved from liability in such circumstances. Application of such a bright-line and rigid rule would tend to not effectuate the intent of the parties and render such contracts otherwise meaningless.

Id. at 270.

The Court found that the GKTW liability release form released GKTW and all of its agents, officers, directors, servants and employees from “any liability whatsoever in connection with the preparation, execution and fulfillment of said wish…” The release then provided that the scope of the agreement included “damages or losses or injuries encountered in connection with transportation, food, lodging, medical concerns (physical and emotional), entertainment, photographs and physical injury of any kind . . . .” The Court found that the release clearly conveyed that GKTW would be released from any liability, including negligence, for damages, losses, or injuries due to transportation, food, lodging, entertainment and photographs. Id.

The determination of whether an exculpatory clause is enforceable will be determined by the Judge, as the enforceability of a pre-injury release is a question of law. The enforceability there-

fore, will depend on the Judge assigned to the matter. Physicians should not assume that because a patient signed a liability release form the patient does not have a viable cause of action. Physicians should consult with an experienced attorney who can examine the facts of the case and help you determine the best path forward. The Health Care Practice Group at Pearson Doyle Mohre and Pastis, LLP is committed to assisting Clients in navigating and defending medical malpractice claims. For more information and assistance, please contact David Doyle and Julie Tyk at Pearson Doyle Mohre & Pastis, LLP.

Julie A. Tyk, JD, is a Partner with Pearson Doyle Mohre & Pastis, LLP. Julie concentrates her practice in medical practice defense litigation, insurance defense litigation and health care law. She has represented physicians, hospitals, ambulatory surgical centers, nurses and other health care providers across the state of Florida. She may be contacted by

calling (407) 951-8523; jtyk@pdmplaw.com. 

Your Patient Is Not Happy with Their Knee or Hip Replacement. What’s Next?

By George J. Haidukewych, MD

According to the Agency for Healthcare Research and Quality, more than 790,000 knee and 450,000 hip replacements are performed in the United States each year. While these numbers declined somewhat over the past year due to obvious reasons and events related to the pandemic, experts project a significant upward trend in medically indicated joint replacement surgeries over the next 10 years.

More than 85-90 percent of patients who undergo total knee or hip arthroplasty (TKA/THA) surgery experience a favorable outcome, with a decrease in pain, an increase in mobility and an overall improved quality of life. And with advances in technology, patients can expect their replacement joint to function well for 20 years or longer. But not all joint replacement surgeries are successful. Complications and failures can occur, and patients who expected dramatic pain relief and function after a knee or hip replacement may present with persistent pain, as well as considerable frustration and unhappiness.

About a third of patients will still have some aches and pains following knee or hip replacement. Early problems can be due to technical factors involving the surgery, inadequate rehab, or more serious problems such as infection or loosening. Problems can also occur years after surgery as the ceramics and plastics start to wear through. A joint replacement that had previously been functioning well for several years can suddenly start hurting or swelling.

The most common complaints following TKA include swelling, activity-related pain and mechanical symptoms, like a crunching behind the kneecap and even clicking when the patient walks. With THA, common painful symptoms include persistent pain around the tendon or bursa on the side of the hip. WHEN IS REVISION SURGERY NECESSARY?

WHAT DO YOU DO IF YOUR PATIENT EXPERIENCES PERSISTENT PAIN AFTER JOINT REPLACEMENT SURGERY?

Sorting out what is a normal discomfort for a prosthetic joint and what is a more serious problem is not always straightforward. What may seem like a minor ache or pain could be a sign of a more serious underlying problem. Problems such as instability or loosening of the knee or hip, or even more unusual problems like corrosion or metal sensitivity, can be easily misdiagnosed; ruling out infection and instability is critical.

The optimal plan of care for those patients who continue to experience ongoing joint pain after TKA or THA is an evaluation referral with an orthopedic specialist. Specialized tertiary referral centers like Orlando Health Jewett Orthopedic Institute offer expert specialist care and advanced technology, including leading-edge imaging, such as MRI scanning with metal artifacts suppression, to diagnose reasons for persistent symptoms after a knee or hip replacement.

Sometimes patients have unrealistic expectations of their replacement, because of what they’ve been told or seen on TV or social media. Expecting the joint to be normal versus artificial is a common source of dissatisfaction. They may not follow proper rehab or activity levels. These patients require a comprehensive evaluation of their overall fitness level, including other joints like the shoulders and ankles. Patients need to focus on total body fitness and understand what a replacement joint can and cannot do.

An overall aging population, a rise in the prevalence of risk factors such as obesity, and the popularity of maintaining active lifestyles not only contribute to the increasing number of joint replacement surgeries, but also the inevitable consequential increase in complications or failed joint replacements. We also have seen an increasing number of joint replacements in a younger patient population whose active lifestyles place added stress and wear on their original and replacement joints. With normal use and activity, every joint replacement implant begins to wear over time, and excessive activity or weight may increase the rate of this normal wear, causing the replacement joint to loosen and become painful.

Evaluation by an orthopedic specialist may determine that a painful knee or hip replacement does need any further surgical intervention. It may simply be something that indicates additional physical therapy, weight loss or activity modification. But there is an increasing number of patients who will require a joint replacement revision (redo).

Revision, or redo, surgery is a complex procedure that involves removing and replacing the original joint implant, usually due to a complication from the initial replacement.

Overall, complication rates following TKA or THA surgery are low. Serious complications, such as a joint infection, occur in fewer than 1-2 percent of patients. Instability can occur in 2-3 percent of knee replacements, and 2-3 percent of hip replacements can have a dislocation or similar problem. These percentages are small, but given the large number of surgeries performed, it adds up to a significant number of people experiencing undue discomfort and pain.

Typically, more women than men undergo knee replacement, with hip replacements being about even between men and women. Overall, men place more wear on replacement joints than women, due both to more body weight and slightly more activity, resulting in a slightly higher need for revision surgery.

Data from Medicare shows that the average rate of revision

surgery within 90 days is 0.2 percent but increases to 3.7 percent within 18 months. These are usually due to infection or mechanical complications of the implant. While surgical techniques and implant designs and materials continue to advance, implant surfaces can wear down and the components can loosen over time. Research suggests that long-term wear and loosening affects 6 percent of people after 5 years and 12-15 percent after 10 years.

Only a handful of centers in Florida specialize in diagnosing and treating conditions associated with problematic joint replacements. Specialists with the Orlando Health Jewett Orthopedic Institute perform hundreds of successful revisions of knee and hip replacements every year for patients throughout Florida and the Southeast.

These complex, long procedures can be challenging and require multidisciplinary and subspecialty care, including infectious disease experts and plastic surgeons, as well as advanced surgical, intensive care, recovery and rehabilitation facilities that provide a higher level of care. Backed by all the resources of the Orlando Health system, Orlando Health Jewett Orthopedic Institute offers this advanced level of care. And, expected to be completed in 2023, a new, state-of-the-art orthopedic complex on Orlando Health’s downtown Orlando campus will usher in the next generation of orthopedic care.

Ultimately, the basic message for your patients is “Don’t give up hope!” An orthopedic surgeon who specializes in complex knee and hip revision work can provide a comprehensive evaluation to determine how to best correct a persistent joint replacement problem.

Internationally recognized for joint replacement surgery and trauma, George J. Haidukewych, MD, serves as Orlando Health’s director of orthopedic trauma and chief of complex joint replacement, practicing at the Orlando Health Jewett Orthopedic Institute. Dr. Haidukewych specializes in total hip and total knee replacements as well as orthopedic trauma. He brings extensive experience in the management of failed and infected total hip and total knee replacements and in reconstruction of the joints after trauma. Up to half of his practice is dedicated to solving these challenging problems from around the Southeast. Dr. Haidukewych completed his residency training at the Mayo Clinic in Rochester, Minnesota, as well as a fellowship at Florida Orthopaedic Institute in the

Tampa Bay area. 

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